A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct will be performed under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching, whereas participants in the post-phase will be managed incorporating the TriVerity™ Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions. Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance, patient disposition, appropriate use of antimicrobials (antibiotics and antivirals) and health economic findings. Safety measures for participants in the post-phase will include patient follow-up at predefined time points. The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care. Improvements based on diagnostic (bacterial vs viral vs non-infectious inflammation) and prognostic (need for 7-day ICU level care) readouts of the TriVerity Test result will be tracked.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Participants in the post-phase of the study will have a 2.5 ml whole blood draw obtained via venipuncture into a PAXgene® Blood RNA tube. Blood samples will be processed using the TriVerity Cartridge on the Myrna Instrument located in the ED.
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, United States
RECRUITINGJohns Hopkins Department of Emergency Medicine
Baltimore, Maryland, United States
RECRUITINGSEP-1 bundle compliance
Mandatory hospital procedures for patients admitted with suspected sepsis
Time frame: Within 72 hours of ED admission
Time to final ED disposition order
Time from Triage (on Day 0) to the Time the ED physician orders the subject disposition (i.e., where the subject will go next: admittance or discharge).
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes
Calculated based on number of patients given antibiotics in ED
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Emergency Department LOS
Length of Stay
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Diagnostic ordering practices
Capturing the diagnostic ordering practices of attending physician (comparing physician choices and decisions before and after the TriVerity Test)
Time frame: Date of enrollment (Day 0) to 72 hours
Hospital admission rates
Overall admission rates for patients that meet study criteria from emergency department to other location (e.g., ICU)
Time frame: Date of enrollment (Day 0) to 72 hours
Total hospital costs
Overall hospital costs for patients that meet study criteria
Time frame: Date of enrollment (Day 0) to 28 days
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